[Remote] Senior Clinical Research Associate - IVD
Note: The job is a remote job and is open to candidates in USA. Clinovo is seeking a Senior Clinical Research Associate for a 3-4 year study that is currently in the startup phase with 3 of 30 sites activated. The role involves overseeing data review, ensuring compliance with regulatory requirements, and managing site activities, with a significant amount of travel expected.
Responsibilities
- Oversee data review, query resolution, and Source Data Verification (SDV) in EDC systems
- Support site management activities including site initiation, monitoring, and close-out (remote and onsite)
- Ensure compliance with study protocols, ICH-GCP, FDA, and global regulatory requirements
- Maintain and audit eTMF, ISF, and essential regulatory documents
- Monitor subject recruitment, data entry timelines, and protocol deviations
- Manage investigational product (IP) tracking and accountability
- Train site staff on protocol and GCP compliance
- Assist with development of CRFs, informed consent forms, and monitoring plans
- Contribute to CAPA development, audit readiness, and inspection support
- Collaborate cross-functionally to meet trial milestones
- Utilize EDC, CTMS, and other clinical trial systems efficiently
Skills
- Worked for a sponsor, preferably IVD or Device but would consider drug development
- Ability to take initiative, tech savvy
- Bachelor's in Life Sciences or related field
- 4+ years in clinical research; IVD and site monitoring experience required
- Expertise in EDC, CTMS, eTMF, and regulatory compliance
- Strong problem-solving, communication, and organizational skills
- Preference for East coast or Central
Company Overview
Company H1B Sponsorship